Budenofalk capsules 3mg, No. 20

• Mild to moderate Crohn's disease involving the ileum and / or ascending colon.

The recommended daily dose is one capsule (containing 3 mg of budesonide) 3 times a day (morning, noon and evening).

The capsules should be taken approximately 30 minutes before meals, swallowing them whole with a sufficient amount of liquid (for example, a glass of water).

Patients with impaired swallowing can open the capsules and directly swallow all microspheres with sufficient fluid.

At the same time, the effectiveness of Budenofalk does not decrease.

The course of treatment is usually 8 weeks. As a rule, the full effect occurs in 2-4 weeks.

You can not abruptly stop taking Budenofalk, you must gradually reduce the dose.

One capsule contains:

Active substance : budesonide -3.00 mg

Excipients : sugar pellets (sucrose 80% + corn starch 20%), lactose monohydrate, povidone K25, Eudragit L, Eudragit S, Eudragit RS, Eudragit RL, talc, dibutyl phthalate, gelatin, purified water, titanium dioxide (E171), red A (crimson 4R, E124), red iron oxide (E172), sodium lauryl sulfate.

• Hypersensitivity to budesonide or other components of the drug,

• infectious bowel diseases (bacterial, fungal, amoebic, viral infections),

• childhood,

• severe liver dysfunction.

With care : tuberculosis, arterial hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes or glaucoma.

Trade name of the drug : Budenofalk

International Non-Proprietary Name (INN) : Budesonide

Dosage form : capsules 3 mg

Ingredients :

One capsule contains:

Active substance : budesonide -3.00 mg

Excipients : sugar pellets (sucrose 80% + corn starch 20%), lactose monohydrate, povidone K25, Eudragit L, Eudragit S, Eudragit RS, Eudragit RL, talc, dibutyl phthalate, gelatin, purified water, titanium dioxide (E171), red A (crimson 4R, E124), red iron oxide (E172), sodium lauryl sulfate.

Description : Hard gelatinous opaque red capsules containing round white pellets (granules). Capsule size No. 1.

Pharmacotherapeutic group : Glucocorticosteroid

PHARMACHOLOGIC EFFECT

Budesonide is a non-halogenated glucocorticosteroid with anti-inflammatory, anti-allergic, anti-exudative and decongestant properties.
These properties are based on:
- a decrease in the release of mediators from mast cells, basophils and macrophages,
- a redistribution and suppression of the migration of inflammatory cells, inhibition of inflammatory reactions;
- membrane stabilizing action.
The induction of certain proteins (eg, macrocortin) is possibly one of the specific mechanisms of action of budesonide. By inhibiting phospholipase A2, these proteins are involved in the metabolism of arachidonic acid and thus prevent the formation of inflammatory mediators leukotrienes and prostaglandins. Since the process of induction of protein synthesis takes a certain period of time, the full therapeutic effect of budesonide develops gradually.

Pharmacokinetics

Budesonide has pronounced lipophilic properties and is rapidly absorbed in the intestine due to good tissue permeability.
Compared with classical glucocorticosteroids, budesonide has a very high affinity for the receptors. Thanks to these properties, Budenofalk has a targeted local action. Approximately 90% of budesonide is metabolized in the liver in the 'first pass' and only about 10% has a systemic effect. Of this amount, 90% of budesonide is bound to albumin and, due to this, is in a biologically inactive form.

INDICATIONS FOR USE

• Mild to moderate Crohn's disease involving the ileum and / or ascending colon.

CONTRAINDICATIONS

• Hypersensitivity to budesonide or other components of the drug,

• infectious bowel diseases (bacterial, fungal, amoebic, viral infections),

• childhood,

• severe liver dysfunction.

With care : tuberculosis, arterial hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes or glaucoma.

DOSAGE AND APPLICATION

The recommended daily dose is one capsule (containing 3 mg of budesonide) 3 times a day (morning, noon and evening).

The capsules should be taken approximately 30 minutes before meals, swallowing them whole with a sufficient amount of liquid (for example, a glass of water).

Patients with impaired swallowing can open the capsules and directly swallow all microspheres with sufficient fluid.

At the same time, the effectiveness of Budenofalk does not decrease.

The course of treatment is usually 8 weeks. As a rule, the full effect occurs in 2-4 weeks.

You can not abruptly stop taking Budenofalk, you must gradually reduce the dose.

SIDE EFFECT

Side effects typical of systemic glucocorticosteroids (Cushing's syndrome) can sometimes occur.

These side effects depend on the dose, duration of treatment, concomitant or previous treatment with other glucocorticosteroids, and individual sensitivity.

Clinical trials have shown that the incidence of side effects characteristic of glucocorticosteroids with Budenofalk is significantly less (approximately 2 times) compared to the incidence of adverse effects with oral administration of equivalent doses of prednisolone.

However, the occurrence of side effects typical of glucocorticosteroids cannot be completely ruled out.

The following side effects may occur:

On the part of the skin :
Allergic eczema, red striae, petechiae, ecchymosis, steroid acne, impaired wound healing, contact dermatitis;
From the side of the musculoskeletal system :
Muscle weakness, osteoporosis, aseptic necrosis of bones (femur and humeral head);
From the senses :
Glaucoma, cataracts;
On the part of the mental status :
Depression, euphoria, irritability;
From the gastrointestinal tract :
Cushing's syndrome (moon face, obesity of the trunk, diabetes mellitus, decreased glucose tolerance, sodium retention with the formation of edema, hypokalemia, decreased function or atrophy of the adrenal cortex, impaired secretion of sex hormones (amenorrhea, hirsutism, impotence);
from the cardiovascular system :
increased blood pressure, increased risk of thrombosis, vasculitis (canceled after prolonged treatment syndrome);
immune system :
Effect on immune response (increased risk of infectious diseases).
When transferring patients receiving systemic corticosteroids at the budesonide, can be amplified or newly occur extraintestinal symptoms (especially skin and joint damage).

INTERACTION

Cardiac glycosides
The effects of cardiac glycosides may be enhanced by potassium deficiency.
Saluretics
Glypokalemia may increase.
Inhibitors of cytochrome P450 (ketonazole, troleandomycin, erythromycin, cyclosporin).
The glucocorticosteroid effect may be enhanced.
The simultaneous appointment of cimetidine and budesonide can lead to a slight increase in the level of budesonide in plasma, but this has no clinical significance.
Concomitant administration of omeprazole does not affect the pharmacokinetics of budesonide.
Theoretically, interaction with resins capable of binding steroids (for example, cholestyramine), as well as antacids, cannot be excluded. With the simultaneous administration of these drugs with Budenofalk, as a result of interaction, the therapeutic effect of budesonide may decrease. In this regard, the above drugs should be taken with Budenofalk at least 2 hours apart.

SPECIAL INSTRUCTIONS AND PRECAUTIONS

Budenofalk can suppress the function of the hypothalamic-pituitary-adrenal system. Before surgery or exposure to another stress factor, additional administration of systemic glucocorticosteroids is recommended.

APPLICATION DURING PREGNANCY AND LACTATION

During pregnancy, the use of Budenofalk is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus. In women of childbearing age, before starting therapy with Budenofalk, possible pregnancy should be excluded, and reliable methods of contraception should be used during treatment. Until now, it is not known whether budesonide is able to penetrate into breast milk, therefore, during the period of treatment, it is necessary to stop breastfeeding.

RELEASE FORM

10 capsules in an Aluminum / PVC blister, 2 or 5 or 10 blisters with instructions for use in a cardboard box.

STORAGE CONDITIONS

The drug is stored at a temperature not exceeding 25 ? C, out of the reach of children.

SHELF LIFE

3 years. Do not use after the expiration date printed on the package.

TERMS OF RELEASE FROM PHARMACIES
On prescription.